英語版 15-03
Revised October 1, 2019 (Revision 4)

Identification Number: 226AABZX00069000
Controlled Medical Device –Bonding Material for Dental Metal
Bonding Material for Dental Ceramics
Bonding Material for Dental Resin

Multi Primer[ Instructions ]Curing procedure is as given in the table.

Process

LED CURE Master*

Other curing machine

Curing Multi Primer PASTE

About 10 sec.

About 90 sec.

Curing Multi Primer
REPAIR LIQUID ONE

About 10 sec.

About 60 sec.

*LED light curing machine from Yamakin[ Indications ]Multi Primer is suitable for use with dental metal restoration materials and devices, or for use with dental zirconia
restoration materials and devices, or for use with dental resin restoration materials and devices. In particular,Multi Primer PASTE is suitable for use with metals. Multi Primer LIQUID is suitable for use with metals andzirconia. Multi Primer REPAIR LIQUID ONE is available for work with resins. Offering firm resin adhesion, Multi
Primer enhances operability in resin application.

[ Contraindications and Prohibitions ]DO NOT USE THIS PRODUCT ON PATIENTS WHO HAVE A HISTORY OF ALLERGY SUCH AS IRRITATION
TO THIS PRODUCT OR METHACRYLIC ACID SERIES OR METHACRYLATE MONOMER.

[ Shapes, Composition and Description ]This product consists of the following items and contains ingredients below.
Item

StateIngredients

Multi Primer PASTE

Paste

methacrylate monomer, inorganic fillers, pigments, etc.

Multi Primer LIQUID

Liquidethanol, etc.

Multi Primer REPAIR LIQUID ONE

Liquidmethacrylate monomer, etc

Description of these materials is as follows.
Item

Description

Multi Primer PASTEThis material is adhesive primer and cured by visible light.

Multi Primer LIQUIDThis material is adhesive primer.

Multi Primer REPAIR LIQUID ONE

This material is adhesive primer and cured by visible light.

[ Intended use and effect / efficacy ]This product is intended to be used to bond indirect composite resin material to dental restorations and devices
made of metal, zirconia, or resin. Do not use this product for other purposes.

[ Product Specifications ]Item

Testing Material

Specification

Multi Primer PASTE

Metal*¹
Metal *¹30 MPa andover and
30 MPaZirconia*¹

over and
20 MPaover10 MPa andoverMulti Primer LIQUID
Multi Primer REPAIR LIQUIDONEIndirect Composite Resin forDental Crown*¹

Test Method

Compliant withISO/TS11405Tensile BondStrength

8 MPa and overDental Acrylic Resin *²*1) Indirect composite resin for dental crown is used with the testing materials.
*2) Dental acrylic resin is used with a testing material.

Prior to use, carefully read the instructions manual.

[ Materials for use in combination with Multi Primer Series ]Indirect composite resin: Luna-Wing and TWiNY[ Instructions for Use ]・In case of Building-Up composite resin for crowns and bridges on a metal framework(1) Making Metal Framework
Make a plaster model in accordance with normal practice. Cut back and make the crown shape using wax; thenapply bonding material and retention beads on facing part to make wax pattern (mould of metal framework).
Then cast the metal following its manufacturer’s instruction.
(2) Alumina Treatment of Metal Framework
Sand-blast (about 0.2～0.25MPa) the surface with alumina powder (about 50μm); then use steam cleaner orultrasonic cleaner to wash, then dry.
(3) Multi Primer PASTE or LIQUID Application and Light Curinga. Multi Primer PASTE Application
Apply Multi Primer PASTE to flow into the undercut area of retention beads. Leave it for about 120 sec., toenhance bonding strength. Light cure.
b. Multi Primer LIQUID Application
Apply Multi Primer LIQUID and leave it about for 60 sec. to dry.
(4) Resin Application
Follow instructions for indirect composite resin and build-up.
Since Multi Primer PASTE is the same shade as the Invisible Opaque shades of Luna-Wing and TWiNY, thelayering step of Invisible Opaque and light curing are not necessary.
・In case of Building-Up composite resin for crowns and bridges on a zirconia framework(1) Making Zirconia Framework
Shape a zirconia framework following manufacturer’s instructions. Design the surface terraced and thelevel differnce should be about 0.1mm.
(2) Alumina Treatment of Zirconia Framework
Sand-blast (about 0.2～0.25MPa) the surface with alumina powder (about 50μm); then use steam cleaner orultrasonic cleaner to wash, then dry.
(3) Multi Primer LIQUID Application
Immediately after washing and drying, apply Multi Primer LIQUID and leave it to dry for about 60 sec.
(4) Resin Application
Follow instructions for indirect composite resin and build-up.
・Additional Layering on Resin Surface(1) Surface Treatment of Resin Surface
Grind resin surface with a carborundum or diamond point and make the surface rough. Use steam cleaner orultrasonic cleaner to wash, and then dry.
(2) Application of Multi Primer REPAIR LIQUID ONE and Light Curing
Apply Multi Primer REPAIR LIQUID ONE and leave undisturbed for about 120 sec. Then, light cure.
(3) Resin Application
Follow instructions for indirect composite resin and build-up.

・Repair of Fractured Resin Surface(1) Preparation of Fractured Surface
Grind fractured surface with a carborundum or diamond point and make the surface receptive for application.
Use steam cleaner or ultrasonic cleaner to wash, and then dry.
(2) Application of Multi Primer REPAIR LIQUID ONE and Light Curing
Apply Multi Primer REPAIR LIQUID ONE and leave undisturbed for about 120 sec. Then, light cure.
(3) Resin Application
Follow instructions for indirect composite resin and build-up.

[ N.B.: Technical Directions and Points for Attention ]1. For light-curing this product, use a halogen lamp, xenon lamp, metal halide lamp or LED with an effective
wavelength of 400-500 nm. In cases where other medical curing equipment is to be used, or if you have anyquestions about curing machines, please feel free to contact us.
2. Close the cap promptly and tightly after using this product.
3. Use separate brushes for Multi Primer PASTE, Multi Primer LIQUID, and Multi Primer REPAIR LIQUID
ONE.
4. Thoroughly check in advance all instructions and precautions for each medical device to be used in combination
with this product.
5. Do not apply Multi Primer LIQUID onto a framework directly. Too much Primer might get poured onto theframework, making the bonding strength weaker. Apply primer onto a round thin brush and then apply it onto
the framework as thinly as possible.
6. Apply Multi Primer LIQUID onto a zirconia framework immediately after it has been washed and dried. Thebonding strength will be significantly weaker if the framework is left undisturbed after drying, for reasons suchas impurities adhering to the surface of the framework, etc.
7. When this material is used on a pallet or mixing paper, it should be protected by a shade cover.
8. During application, avoid placing in areas with strong light, such as near windows, or directly under lighting.
Doing so may cause curing of the material.
9. It is recommended to use this product for performing restoration outside the mouth.

[ Precautions ]① Multi Primer LIQUID is flammable. Do not use this product in proximity to fire.
② Provide adequate ventilation (several times per hour) during operation.
③ When cutting and polishing cured product, use exhaust fan and anti-dust mask as approved by your local public
safety agency in order to avoid inhaling dust. Wear safety goggles to protect the eyes.
④ Do not use this product outside the scope of recommended indications, effects or potency.
⑤ Do not mix this product in combination with other bonding products for metals, zirconia or resins. Doing somay impair the functionality of this product.
⑥ Only adequately certified personnel should handle this product.
*It is recommended to use this product at an ambient temperature of 20-25℃ for easy handling.

[ Important Basic Cautions ]① Stop using this product immediately if any signs of allergy, such as irritation or rush, appears in patients. If
symptoms persist, seek medical attention.
② Operators must discontinue use if any signs of irritation or rash appear. If symptoms persist, seek medicalattention.
③ Do not touch uncured material of this product with bare hands. Wear plastic gloves and safety goggles to protectfrom irritation. Avoid direct skin and eye contact. In case of skin contact, wipe with alcohol cotton swab, andflush with plenty of running water. In case of eye contact, immediately flush with plenty of running water, andconsult a physician.

[ Handling and Storage ]① This product must be stored in out of contact with direct light sources at a temperature of 4-25℃② Do not store too many products in the same storage area.
③ Equip with a fire extinguisher in work or storage area.
④ Keep out of reach of personnel other than dental staff.

[ Expiry Date ]① This product must be used before the expiry date printed on the package.
② The expiry date printed on the package is based on our authentication.
③ The expiry date printed on the package refers to use expiry date.
*(ex.: YYYY-MM means the last day of YYYY ‘year’/MM’ month’ as the expiry date)[ Package ]①Multi Primer PASTE 2ml②Multi Primer LIQUID 7ml③Multi Primer REPAIR LIQUID ONE 6ml